Nonclinical Writer

MMS; Baltimore (MD); Remote; USD 78,720 - 108,240; Full time

Job summary

A leading clinical research organization is seeking a technical writer to develop and manage nonclinical documents. This full-time remote position requires a BS in pharmacology or related fields, with a minimum of 2 years in regulatory writing. Candidates should possess strong analytical skills and familiarity with regulatory guidelines. Join an innovative team shaping the future of clinical research.

Qualifications

• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsibilities

• Lead the writing of nonclinical documents and ensure alignment with regulatory guidelines.
• Collaborate with cross-functional teams on complex projects.
• Interpret and analyze pharmacokinetics, pharmacology, and toxicology data.

Skills

Strong writing and analytical skills

Organizational expert within the nonclinical subject area

Excellent written/oral communication

Ability to work in various client systems

Negotiation and collaboration skills

Education

BS + in pharmacology, toxicology, biology or chemistry

Tools

MS Office applications

Job description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award‑winning, data‑focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry‑leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full‑time, remote position.

Referrals increase your chances of interviewing at MMS by 2x.

Roles and Responsibilities

• Strong experience with development and writing of nonclinical documents (e.g., Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
• Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
• Ability to author based on highly technical sources such as GLP and non‑GLP nonclinical study reports, in vivo and in vitro nonclinical data
• Ability to develop a mapping plan for the placement of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD submission documents
• Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (e.g., Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports)
• Collaborate with cross‑functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC
• Demonstrated ability to lead others to complete complex projects
• Ability to complete documents according to sponsor’s format, processes, and regulatory guidelines
• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
• Organizational expert within the nonclinical subject area
• Excellent written/oral communication and strong time and project management skills
• Ability to attend regular team meetings, lead client meetings and CRMs
• Ability to work in various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
• Strong understanding of regulatory guidance as it applies to nonclinical submission documents and drug development (e.g., ICH, FDA, and EMA regulations and guidelines, GLP, GCP, GMP, and GDP)

Requirements

• BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
• 2+ years of pharmaceutical regulatory nonclinical writing experience
• Strong writing and analytical skills
• Proficiency with MS Office applications
• Hands‑on experience with clinical trial and pharmaceutical development preferred
• Basic understanding of CROs and scientific & nonclinical data/terminology, and the drug development process

Location: Baltimore, MD. Salary: $78,720.00 – $108,240.00.